Table 3 Adverse events reported in at least 20% of patients of any (safety population)
Event (n(%)) System organ class Preferred term | Arm A (n = 29) | Arm B (n = 28) | ||
|---|---|---|---|---|
All Grades | Grade 3/4 | All Grades | Grade 3/4 | |
Blood and lymphatic system disorders | 7 (24.1%) | 1 (3.4%) | 7 (25.0%) | 3 (10.7%) |
Anemia | 6 (20.7%) | 1 (3.4%) | 6 (21.4%) | 2 (7.1%) |
Gastrointestinal disorders | 22 (75.9%) | 1 (3.4%) | 26 (92.9%) | 7 (25.0%) |
Constipation | 5 (17.2%) | - | 6 (21.4%) | - |
Diarrhea | 12 (41.4%) | - | 16 (57.1%) | 3 (10.7%) |
Mucositis oral | 9 (31.0%) | - | 12 (42.9%) | - |
Nausea | 6 (20.7%) | - | 9 (32.1%) | 2 (7.1%) |
General disorders and administration site conditions | 20 (69.0%) | 1 (3.4%) | 22 (78.6%) | 3 (10.7%) |
Edema limbs | 8 (27.6%) | - | 1 (3.6%) | - |
Fatigue | 13 (44.8%) | - | 14 (50.0%) | - |
Pain | 8 (27.6%) | - | 9 (32.1%) | 1 (3.6%) |
Investigations | 7 (24.1%) | 1 (3.4%) | 14 (50.0%) | 9 (32.1%) |
White blood cell decreased | 3 (10.3%) | 1 (3.4%) | 12 (42.9%) | 7 (25.0%) |
Metabolism and nutrition disorders | 3 (10.3%) | 1 (3.4%) | 14 (50.0%) | 1 (3.6%) |
Anorexia | 1 (3.4%) | - | 12 (42.9%) | 1 (3.6%) |
Nervous system disorders | 21 (72.4%) | 3 (10.3%) | 18 (64.3%) | 6 (21.4%) |
Dizziness | 6 (20.7%) | - | 1 (3.6%) | - |
Dysgeusia | 1 (3.4%) | - | 7 (25.0%) | - |
Peripheral sensory neuropathy | 17 (58.6%) | 2 (6.9%) | 11 (39.3%) | 4 (14.3%) |
Respiratory, thoracic and mediastinal disorders | 14 (48.3%) | 1 (3.4%) | 17 (60.7%) | 2 (7.1%) |
Epistaxis | 6 (20.7%) | - | 7 (25.0%) | - |
Skin and subcutaneous tissue disorders | 15 (51.7%) | - | 20 (71.4%) | 3 (10.7%) |
Alopecia | 12 (41.4%) | - | 6 (21.4%) | - |